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CTRI Number  CTRI/2024/10/075241 [Registered on: 14/10/2024] Trial Registered Prospectively
Last Modified On: 01/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Ayurveda 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   To see effect of One Ayurvedic Formulation with other kwath in treatment of Gridhrasi with Reference to Sciatica 
Scientific Title of Study   A Randomized Controlled Clinical trial to Evaluate the Efficacy Of Hingwadi Kwath and Shefali Patra Kwath in the Management of Gridhrasi w s r to sciatica 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rahul Mahadeo Kalore 
Designation  MD Kayachikitsa Scholar  
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya,Patur,Akola 
Address  Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA Akola MAHARASHTRA 444501

Akola
MAHARASHTRA
444501
India 
Phone  8605717221  
Fax    
Email  rk8605717221@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Jayshree Katole 
Designation  Professor and Head of the Department,Kayachikitsa 
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya 
Address  OPD NO 3 Department of Kayachikitsa,Dr VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA Akola MAHARASHTRA

Akola
MAHARASHTRA
444501
India 
Phone  9423847608  
Fax    
Email  drjrkatole@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Jayshree Katole 
Designation  Professor and Head of the Department,Kayachikitsa 
Affiliation  Dr.VJD Gramin Ayurved Mahavidyalaya 
Address  OPD NO 3 Department of Kayachikitsa,Dr VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola Pin-444501 MAHARASHTRA INDIA Akola MAHARASHTRA

Akola
MAHARASHTRA
444501
India 
Phone  9423847608  
Fax    
Email  drjrkatole@gmail.com  
 
Source of Monetary or Material Support  
Department of Kayachikitsa,Dr VJD Gramin Ayurved Mahavidyalaya,Patur,Dist-Akola,Maharashtra,India Pin code -444501 
 
Primary Sponsor  
Name  Dr.VJD Gramin Ayurved Mahavidyalaya 
Address  Dr.VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,Patur,Tal-Patur,Dist-Akola,Maharashtra,India Pin-444501 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rahul Kalore   Dr.VJD Gramin Ayurved Mahavidyalaya  OPD no 3 , Department of Kayachikitsa,Dr VJD Gramin Ayurved Mahavidyalaya,near Renuka mata mandir,P atur,Tal-Patur,Dist-Akol a Akola MAHARASHTRA
Akola
MAHARASHTRA 
8605717221

rk8605717221@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee,DR VJD Gramin Ayurved Mahavidyalaya,Patur, Akola  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition:G570||Lesion of sciatic nerve. Ayurveda Condition: GRUDHRASI,  
 
Intervention / Comparator Agent  
snoIntervention/ComparatorTypeDrug-TypeProcedure NameDetails
1Intervention ArmDrugClassical(1) Medicine Name: Hingwadi Kwath , Reference: Sharangdhar Dwitiya khand 2/78 , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -koshna jal ), Additional Information: -
2Comparator ArmDrugClassical(1) Medicine Name: Shefali Patra Kwath, Reference: Bhaishajya Ratnavali , Route: Oral, Dosage Form: Kwatha/ Kashaya, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 30 Days, anupAna/sahapAna: Yes(details: -Koshna jal), Additional Information: -
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients showing classical symptoms and sign of Gridhrasi as described in
ayurvedic samhitas.
Radiating pain along the course and distribution of sciatic nerve that is in buttock
to outer border of foot.
2.SLR Test of patient – positive up to 60degree.
3. Patients between the age of 20-60 years.
4.Patients from all socio-economic status.
5. Either sex 
 
ExclusionCriteria 
Details  1. Patients not willing.
2. Pregnant and lactating mothers.
3. Infective disorders – T.B. of spine, osteomyelitis, etc.
4. Patients with paraplegia of lower limb.
5. Fracture of spinal bones or in lower extremity bones.
6. Patients having congenital anomalies with lumbosacral
spine such as kyphosis, scoliosis.
7.Patients having any major chronic/acute;
systemic/surgical Pathology.
8.Patients with deep wounds penetrating till sciatic nerve.
9. Diabetes Mellitus.
10. Patient below 20 yrs age and above 60 yrs age 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1) Sphikpurvakati, Uru, Janu, Jangharuja (Pain).
2) Stambha (Stiffness)
3) Toda (Pricking sensation)
4) Spandan (Twitching)
5) Parshni pratyangulivedna
6) Agnimandya
7) Aruchi
Will be decreased  
Above mentioned Symptoms
Will be decreased  
 
Secondary Outcome  
Outcome  TimePoints 
Decreased symptoms completely   1 month 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   16/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Gridhrasi is one of the Nanatmaja Vata Vyadhi caused by Vitiation of vayu.
The name Gridhrasi is derived From the word "Grudhra" that literally means a "vulture".
 The Patient suffering From this disease walks like a vulture(Grudhra) due to severe,
persistant & migrating pain, so the name of this disease or vyadhi is"Gridhrasi". If the
patient right leg is affected by Gridhrasi Vyadhi patient bears all his weight on his left leg
& vice versa. This typical gait looks like that of Grudhra’s (vulture’s) walk hence this
disease is called Gridhrasi. These Symptoms are similar to the symptoms of "sciatica"
described in modern medical science. The Pratyatma Lakshana of Gridhrasi is migrating
pain from Sphika (hip), Kati(waist). Prushta(back), uru(groin), Janu(knee) & Jangha(thigh)
to pada(foot). Classical pain of Gridhrasi is accompanied by Stambha(rigidity),
Ruja(pain), Tod (Pricking pain) & the patient feels recurrent through along affected leg.
 The objective of this cross-sectional study was to estimate the 6 month Prevalence
and severity of low back pain & sciatica in a representative sample of 674 adults aged 20
years or older from a mainly (74.8%) urban population. Information regarding low back
pain & sciatica prevalence & severity & its related aspects, as well as socioeconomic &
demographic characteristics was collected by personaI interviews with a validated
questionnaire. A total of 266(39.5%) patients reported low back pain &166(24.68)
reported sciatica during the previous 6 month period.
 The lifetime Prevalence of a low back pain is reported to be more than 70%
in industrialized countries. 1 year prevalence 15% to 45% adult incidence 5% per year
with varying degrees of symptom severity.
 The prevalence of low back pain during school age approaches that seen in adult.
Increases from childhood to adolescence and peaks between age 35 & 55 years.

Gridhrasi is one among the 80 types of Vataj Nanathmaja Vyadhis. The chances of
Gridhrasi is expected to increase in the upcoming years due to sedentary life style, the
increased used of computerization & also due to increasing body weight, mental stress
hectic work schedules & excessive travelling. 

All these adds on to the improper posture which is one of the highlighted cause for
spine & nerve compression disorder in the present scenario.
 Low back pain is the 2nd most common reason for all physician visits & it is condition
that affects as many as 80-90% of people during their life time, among them true sciatica
causes occurs in about 5% cases. On considering sciatica as an independent disease it is
relatively common condition with life time incidence varying from 1.6% -43%. Sciatica is
more common among the age group between 20-60-years of age.
 It is a fact that despite recent progress of modern neurology. It is unable to provide
an effective cure for sciatica, except for giving temporary relief through analgesic or
surgical interventions continuous use of NSAIDS and steroids for reliving pain may in
later course. Lead to secondary complication like kidney failure, liver disorder & gastritis.
 Keeping these facts in mind this study has been under taken to bring out a
treatment modality with no side effects & long lasting relief.
 In this study the role of Hingwadi Kwath & Shefali Patra Kwath which is simple &
potent yoga described in Sharangdhar Samhitas and Bhaishajya Ratnavali with specified
indication only on Gridhrasi.
 
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